- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00692653
Personal Patient Profile Prostate (P4) Randomized, Multisite Trial (P4)
The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant.
Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes.
About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Georgia
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Augusta, Georgia, 미국, 30904
- VA Medical Center / Medical College of Georgia
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19111
- Fox Chase Cancer Center
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Texas
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San Antonio, Texas, 미국, 78229
- University of Texas Health Sciences Center at San Antonio
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington Medical Center
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Seattle, Washington, 미국, 98108
- Veterans Administration Puget Sound Health Care System
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Seattle, Washington, 미국, 98104
- Seattle Prostate Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Biopsy-proven diagnosis of prostate cancer, stage I or II
- Diagnosis within the past 6 months
- Has appointment with a consulting specialist at one of the clinical trial sites
- Must be able to read and write English or Spanish at a 6th grade level
- Must not have begun any treatment (except watchful waiting)
- Must be able to complete baseline assessment before target clinician visit.
Exclusion Criteria:
- Advanced prostate cancer
- Diagnosed more than 6 months ago
- Cannot read and write English or Spanish at a 6th grade level
- Does not have appointment at one of the clinical trial sites
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: P4
Participant uses P4 program before meeting with his clinician to discuss treatment options.
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Tailored online decision support system for prostate cancer treatment decision making
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간섭 없음: Usual care+
Usual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Decisional Conflict
기간: Baseline to 6 months
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Baseline to 6 months
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Decisional Satisfaction
기간: Baseline to 6 months
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Baseline to 6 months
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Satisfaction with Preparation for Decision Making
기간: Baseline to 1 month
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Baseline to 1 month
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Shift in decisional control preference from pre-decision to 1 month post-treatment
기간: Baseline to 1 month
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Baseline to 1 month
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Resource utilization
기간: Baseline to 6 months
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Baseline to 6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Seth Wolpin, RN, PhD, University of Washington
- 연구 책임자: Donna L Berry, RN, PhD, Dana-Farber Cancer Institute
간행물 및 유용한 링크
일반 간행물
- Underhill ML, Hong F, Berry DL. When study site contributes to outcomes in a multi-center randomized trial: a secondary analysis of decisional conflict in men with localized prostate cancer. Health Qual Life Outcomes. 2014 Oct 25;12:159. doi: 10.1186/s12955-014-0159-3.
- Bosco JL, Halpenny B, Berry DL. Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer. Health Qual Life Outcomes. 2012 Sep 28;10:123. doi: 10.1186/1477-7525-10-123.
- Berry DL, Wang Q, Halpenny B, Hong F. Decision preparation, satisfaction and regret in a multi-center sample of men with newly diagnosed localized prostate cancer. Patient Educ Couns. 2012 Aug;88(2):262-7. doi: 10.1016/j.pec.2012.04.002. Epub 2012 May 17.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1R01NR009692 (미국 NIH 보조금/계약)
- R01NR009692 (미국 NIH 보조금/계약)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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P4에 대한 임상 시험
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University of Alabama at Birmingham아직 모집하지 않음
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University of Alabama at Birmingham모병
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University of Alabama at BirminghamNational Center for Advancing Translational Sciences (NCATS)모집하지 않고 적극적으로
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